Home » Posts tagged 'open orphan' (Page 2)
Tag Archives: open orphan
Open Orphan #ORPH – Final results Reveal Record revenues and EBITDA-profitability accompanied by significant operational progress
Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces its audited final results for the 12 months ended 31 December 2021.
Financial highlights
· Record revenues of £39.0m (2020: £22.2m) achieved representing 76% growth
· £9m improvement in EBITDA generating £2.9m (2020: £(6.1)m)
· Cash and cash equivalents as at 31 December 2021 of £15.7m (2020: £19.2m)
· Significant EPS improvement in 2021 to (0.01)p per share (2020: (1.80)p)
· Order book growth of 11% to £46m future contracted revenue as at 31 December 2021 (2020: £41.6m)
Operational highlights
· Delivered a strong and growing pipeline of new challenge study contract wins
o Served four of the top 10 global biopharma companies in 2021 among a growing client base of over 60 clients
· Substantially expanded the Group’s offering into the respiratory market signing an asthma study with a top three global pharma company
· Completed the world’s first COVID-19 characterisation study which was proven to be safe and well tolerated
· Contract signed to manufacture a SARS-CoV-2 Delta variant challenge agent with Imperial College London, as part of a Wellcome Trust-funded initiative
· Opened a new quarantine clinic on a capital efficient basis to facilitate the growing demand for human challenge studies. This new facility, The Whitechapel Clinic, added 19 quarantine bedrooms for future challenge studies
· FluCamp screened c. 84,000 volunteers for human challenge studies in 2021 (2020: c.68,000); supported by the cost-efficient expansion of volunteer recruitment centre
o New London FluCamp volunteer recruitment centre – converted former coffee shop adjacent to the existing QMB facility
o New Manchester FluCamp volunteer recruitment centre
· Significant CRO experience added to the Board with the appointment of Yamin ‘Mo’ Khan as Non-Executive Director, who was appointed CEO post period end
· In June 2021, completed a distribution in specie to the Company’s shareholders, through the demerger of certain non-core assets into Poolbeg Pharma
Post-period end highlights
· Commenced development of a new influenza challenge model for an existing top five global pharmaceutical client and signed a £14.7m contract for the characterisation and challenge trial to follow
· £7.3m influenza challenge trial and £5m RSV challenge trial contracts signed
· Launched a new Malaria human challenge model and was awarded by an existing Big Pharma client to act as a vaccination site for a Phase II field study
· Opened a new primary FluCamp volunteer recruitment facility in Whitechapel, increasing bed capacity by 44% from 43 beds to 62 beds, and opened a new Manchester volunteer recruitment centre at the same cost as the old facility, but with four times the floor space, doubling the Group’s volunteer screening capacity to 1,000 per week
o Facilities expansion enables the Group to broaden the scope of the business to offer additional clinical trial services outside of its traditional core challenge study offering
Current trading and outlook
As at 1 June 2022, Open Orphan had an order book of signed contracts worth £64.2m which is expected to be recognised across 2022, 2023 and 2024.
Open Orphan’s pipeline of new opportunities continues to grow with a number of further challenge study opportunities at advanced negotiations across influenza, asthma, RSV, malaria and COVID-19. This growth is driven by the increased success and awareness of human challenge trials, and the development of new challenge models. A significant portion of our pipeline includes returning Big Pharma customers, in addition to a wider group of new clients who have observed the benefits of human challenge trials.
Our Venn Life Sciences subsidiary continues to deliver specialist drug development consultancy services across non-clinical and clinical development, pharmacology, CMC and biometry services, acting as a trusted partner to an extensive range of clients.
These developments reaffirm the Board’s expectations of a profitable growing business with revenues in the region of £50m in 2022.The Group is now well positioned and well capitalised to deliver sustainable long-term profitability.
Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “2021 was a milestone year for Open Orphan; the Group achieved record revenues, and recorded full year EBITDA-profitability for the first time – a significant turning point for the business.
“The Group won a record number of human challenge study contracts, serving four of the top 10 global biopharma companies and more than 60 clients in total. We were proud to make a significant contribution to the UK Government’s response to the pandemic by completing the world’s first COVID-19 characterisation study, which furthered our understanding of COVID-19 disease progression. Importantly, the Group accomplished this whilst investing in operational improvements, with volunteer screening and quarantine capacities expanded during the year.
“Post-period end, we have continued our momentum from 2021 into a strong start to trading and significant contract wins. We increased our bed count from 43 to 62, doubled our volunteer screening capacity, and also expanded the scope of our business to offer additional clinical trial services, where we have already signed our first contracts, establishing new revenue streams for the business. We also launched our new Malaria Human Challenge Model, which I believe has further consolidated our position as the leading provider of human challenge trials in infectious and respiratory disease. In my new role as CEO, I look forward to driving further growth across the business this year and converting this substantial progress into value for our shareholders.”
Interested in becoming a volunteer?
hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.
1 Source: Citeline Trialtrove, Jan. 2022 and Pharma R&D Annual Review; IQVIA Institute, Global Trends in R&D – Overview Through 2021; Global Data; Evaluate Pharma; Edison Investment Research; Pitchbook
For further information please contact:
|
Open Orphan plc |
+353 (0) 1 644 0007 |
||
|
Yamin ‘Mo’ Khan, Chief Executive Officer |
|||
|
Liberum Capital (Nominated Adviser and Joint Broker) |
+44 (0) 20 3100 2000 |
||
|
Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King |
|||
|
|
|||
|
finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
||
|
Geoff Nash / James Thompson / Richard Chambers |
|||
|
|
|||
|
Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
||
|
Anthony Farrell |
|||
|
|
|||
|
Walbrook PR (Financial PR & IR) Paul McManus / Sam Allen / Louis Ashe-Jepson |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com +44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0)7747 515393 |
||
Notes to Editors
Open Orphan plc
Open Orphan plc (London and Euronext: ORPH) is a rapidly growing contract research company that is a world leader in testing infectious and respiratory disease products using human challenge clinical trials. The Company provides services to Big Pharma, biotech, and government/public health organisations.
The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases, including the recently established COVID-19 model, and is developing a number of new models, such as Malaria, to address the dramatic growth of the global infectious disease market. The Paris and Breda offices have over 25 years of experience providing drug development services such as biometry, data management, statistics CMC, PK and medical writing to third party clients as well as supporting the London-based challenge studies.
Open Orphan runs challenge studies in London from its Whitechapel quarantine clinic, its state-of-the-art QMB clinic with its highly specialised on-site virology and immunology laboratory, and its newly opened clinic in Plumbers Row. To recruit volunteers / patients for its studies, the Company leverages its unique clinical trial recruitment capacity via its FluCamp volunteer screening facilities in London and Manchester. The newly opened facilities have expanded the scope of the business to enable the offering of Phase I and Phase II vaccine field trials, PK studies, bridging studies, and patient trials as part of large international multi-centre studies.
Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological, and digital (wearable) biomarkers.
Link here for full financial statements
Open Orphan #ORPH – Notice of results
Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials , announces that it will release its full year results for the year ended 31 December 2021 on Tuesday 7 June 2022.
Investor Presentation
Yamin ‘Mo’ Khan, Chief Executive Officer, and Leo Toole, Chief Financial Officer, will be hosting a live online presentation relating to the final results via the Investor Meet Company platform at 6pm on Tuesday 7 June 2022. The presentation is open to all existing and potential shareholders.
Investors can sign up to Investor Meet Company for free and register for the presentation here.
Investors who already follow Open Orphan on the Investor Meet Company platform will automatically be invited.
Questions can be submitted pre-event via your IMC dashboard or in real time during the presentation, via the “Ask a Question” function. Whilst the Company may not be in a position to answer every question it receives, it will address the most prominent within the confines of information already disclosed to the market through regulatory notifications. A recording of the presentation and a PDF of the slides used will be available on the Investor Meet Company platform and the Company’s website afterwards.
UK Investor Magazine Podcast, we discuss #stagflation, Burberry #BRBY Open Orphan #ORPH & Tertiary Minerals #TYM
The UK Investor Magazine is joined by Alan Green for a rundown of key market themes and Uk equities.
We start by looking at Stagflation at the implications for the UK economy and markets. Stagflation is a period of rising inflation, economic contraction, and rising unemployment.
The UK satisfies the first two of these, however, unemployment remains robust. We look at whether rising inflation will soon hit jobs activity and what it could mean for equities.
We also discuss the relationship between the FTSE 100 and US indices and how this may develop if we see recession in the US.
Burberry has posted a respectable set of results and is proving a possible choice for income investors. Margins have improved with sales as the luxury brand jumps back from COVID.
Open Orphan’s valuation is worth attention. One could argue the current market cap doesn’t pay justice to their revenue growth and forecast profitability.
We update on the latest from Tertiary Minerals and their portfolio of assets including a selection in Nevada and Nambia.
Open Orphan #ORPH – £7.3m Influenza human challenge study contract win
Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that hVIVO, a subsidiary of Open Orphan, has signed a £7.3m influenza human challenge study (“Study”) contract with a leading biotechnology company to test its antiviral product using the hVIVO Influenza Human Challenge Study Model.
The randomised, double-blinded, placebo-controlled study will test and assess the antiviral prophylactic and post-inoculation treatment activity of the antiviral in healthy adult volunteers enrolled through the Company’s specialist, tech-enabled volunteer recruitment arm,FluCamp. The Study will be conducted by hVIVO’s team of medics at its state-of-the-art quarantine facilities in London and is expected to commence next year. Revenue from the contract is expected to be recognised across FY23 and FY24.
The Company’s specialised virology laboratories, hLAB, will determine the viral load of the influenza challenge agent used to inoculate volunteers, hLAB will also provide serology services and virology services (viral infectivity assay) for the study.
Influenza is a contagious respiratory illness caused by influenza viruses that affect the nose, throat and the lungs. It can cause mild to severe illness, and occasionally lead to death. According to Financial Times1 analysis of official data in England, since the development of effective vaccines and the emergence of the less severe Omicron variant, influenza is now more lethal than COVID-19. For every 100,000 Omicron infections, 35 will result in death, while the equivalent number of flu infections will lead to around 40 fatalities.
Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “I am pleased to sign a contract with this leading biotechnology company to test its antiviral product using the hVIVO Influenza Human Challenge Study Model. hVIVO has seen a steady increase in flu studies, a reflection of the shift in market sentiment following recent scrutiny of infectious disease data that has outlined the significant threat of flu and the potential of human challenge studies to the advancement of drug development candidates.”
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “We are excited to test the antiviral prophylactic and post inoculation treatment activity against flu infection using the hVIVO Influenza Human Challenge Study Model. hVIVO has pioneered influenza human challenge studies for decades, with our history dating back to the Salisbury Common Cold Clinic.
“Since the advent of effective vaccines and treatments for COVID-19, there has been renewed focus on influenza and official data shows flu is now a more lethal threat. After completing the study, we hope to provide positive data and early proof of concept for our client’s product, in order to accelerate its development into a Phase II programme.”
1‘Vaccines and Omicron mean Covid now less deadly than flu in England’, The Financial Times, by Burn-Murdoch, John, and Barnes, Oliver. Link: https://www.ft.com/content/e26c93a0-90e7-4dec-a796-3e25e94bc59b
Interested in becoming a volunteer?
hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.
Individuals interested in taking part in COVID-19 human challenge study research can learn more at www.UKCovidChallenge.com.
For further information please contact:
|
Open Orphan plc |
+353 (0) 1 644 0007 |
||
|
Yamin Khan, Chief Executive Officer |
|||
|
Liberum Capital (Nominated Adviser and Joint Broker) |
+44 (0) 20 3100 2000 |
||
|
Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King |
|||
|
|
|||
|
finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
||
|
Geoff Nash / James Thompson / Richard Chambers |
|||
|
|
|||
|
Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
||
|
Anthony Farrell |
|||
|
|
|||
|
Walbrook PR (Financial PR & IR) Paul McManus / Sam Allen / Louis Ashe-Jepson |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com +44 (0)7980 541 893 / +44 (0) 7502 558 258 / |
||
Notes to Editors
Open Orphan plc
Open Orphan plc (London and Euronext: ORPH) is a rapidly growing contract research company that is a world leader in testing infectious and respiratory disease products using human challenge clinical trials. The Company provides services to Big Pharma, biotech, and government/public health organisations.
The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models, such as Malaria and COVID-19, to address the dramatic growth of the global infectious disease market. The Paris and Breda offices have over 25 years of experience providing drug development services such as biometry, data management, statistics CMC, PK and medical writing to third party clients as well as supporting the London-based challenge studies.
Open Orphan runs challenge studies in London from its Whitechapel quarantine clinic, its state-of-the-art QMB clinic with its highly specialised on-site virology and immunology laboratory, and its newly opened clinic in Plumbers Row. To recruit volunteers / patients for its studies, the Company leverages its unique clinical trial recruitment capacity via its FluCamp volunteer screening facilities in London and Manchester. The newly opened facilities have expanded the scope of the business to enable the offering of Phase I and Phase II vaccine field trials, PK studies, bridging studies, and patient trials as part of large international multi-centre studies.
Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological, and digital (wearable) biomarkers.
hVIVO has a long history of testing influenza vaccines and treatments, with its history dating back to the Common Cold Unit in Salisbury. The Common Cold Unit was established following the end of the Second World War to investigate the microorganisms which cause typical cold symptoms. It was through this research that the first human coronavirus was discovered in 1960.
Open Orphan #ORPH – Proposal to purchase Poolbeg Pharma shares from distribution in specie shareholders
Open Orphan (ORPH) a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, notes the announcement dated 11 April 2022 from Poolbeg Pharma plc (“Poolbeg”), regarding a number of new investors (“New Investors”) having expressed interest in acquiring up to £1.6m of Poolbeg which are currently locked-up and held in trust by Croft Nominees Limited as a result of the distribution in specie from Open Orphan on 18 June 2021.
As part of these proposals, the New Investors have committed to purchase up to £1.6m of the distribution in specie shares on or around 26 April 2022 at a price of 5.9 pence per share, the closing market price on Friday 8 April 2022. The New Investors have shown great interest in the Poolbeg story, its significant progress since IPO in July 2021, and its capabilities in developing novel products utilising its unique cost-effective model in the fast-growing infectious disease market which is expected to be worth in excess of $250bn by 2025. This is a clear vote of confidence in Poolbeg’s prospects as it enters an extremely exciting phase of its development with its first LPS human challenge clinical trial due to commence in June 2022 with multiple value inflection points expected in 2022 and beyond.
This process will allow the locked-up distribution in specie shareholders in Poolbeg the opportunity to sell part or all of their shareholding, should they wish to do so, prior to receiving the shares once the lock-up period ends on 20 April 2022. The distribution in specie shareholders will receive a letter setting out the New Investors’ proposal and a Form of Election informing them how to participate should they wish to sell some or all of their shares prior to the lock-up ending on 20 April 2022. These proposals are open to all distribution in specie shareholders but participation is at each distribution in specie shareholder’s discretion. For those shareholders who do not participate, the title to their distribution in specie shares will be transferred to them on or around 26 April 2022. If more than £1.6m is offered by way of valid Forms of Election, then the distribution in specie shareholders will be scaled back on a pro-rata basis.
The distribution in specie shares are exempt from income tax for UK resident shareholders due to the advance clearance obtained by the Company from HMRC for a statutory demerger. As such, there should be no UK income tax liabilities for UK resident shareholders on receipt of these shares. The only time that UK resident shareholder will be subject to tax on these shares will be in the event that the shareholder sells them, and in that event there will be a capital gains tax payment due on any chargeable gain. The base cost for capital gains calculation purposes will be 1% of the original cost base of the Open Orphan shares which will be close to nil (0), therefore nearly the full consideration will be subject to capital gains tax. The above comments are intended only as a general guide, shareholders are encouraged and recommended to seek their own financial and tax advice.
Open Orphan plc and Poolbeg Pharma plc ordinary shares are ISA qualifying investments. Open Orphan understands that any distribution in specie shares held in an ISA should be treated in a similar way to any other income generated from ISA qualifying investments.
A copy of the letter to distribution in specie shareholders can be found on Poolbeg’s website here and an FAQ is available here.
Cathal Friel, Executive Chairman of Open Orphan, said: “We were delighted to see that despite the presently turbulent market that Poolbeg has successfully managed to bring in fresh investors to purchase up to £1.6m at 5.9p, the market price on Friday 8 April 2022. The new investors have shown great interest in the Poolbeg story and its significant progress since IPO, its capabilities in developing novel infectious disease products utilising its unique cost-effective model. Poolbeg is well capitalised, with c. £20.9m at year end 2021, so importantly it is not raising any new funds as part of this process and, as such, there will be no dilution of existing shareholders.
“This arrangement has followed significant efforts to help widen the Poolbeg investor base and increase future liquidity, in order to ensure that the dividend in specie remains as beneficial as possible to shareholders of both Open Orphan and Poolbeg in the long-term.
“Due to the nature of the lock-up period, which was designed to allow for an orderly market following Poolbeg’s admission to AIM, prospective investors looking to build more substantial stakes were unable to do so. These proposals ensure that any potential shares sold will be going to quality, long-term holders, whilst giving distribution in specie shareholders the option to sell shares prior to the end of the lock-up period, if they choose to do so. In addition, there will be substantially greater liquidity in our shares once the distribution in specie shares have been distributed after 26 April 2022 and we believe this will certainly help us to attract in even more new shareholders.”
Footnote
The distribution in specie shares were issued to all Open Orphan shareholders on the share register at close of business on 17 June 2021, following this, Poolbeg successfully listed on the London Stock Exchange AIM market on 19 July 2021. While the underlying shareholders retain the beneficial ownership of the shares, the distribution in specie shares are currently held in trust by Croft during a lock-up period of nine calendar months from Poolbeg’s admission to AIM, to contribute to the creation of an orderly market. This lock-up period will end on 20 April 2022 and on or around 26 April 2022, shareholders will be sent a share certificate for the distribution in specie shares. Shareholders will then have the option to dematerialise and hold the shares via CREST. If any Open Orphan shares that gave rise to the entitlement to the distribution in specie shares are held in a nominee account, the share certificate will be sent to the shareholders’ broker.
The New Investors’ proposals are not open for participation by persons interested in shares who are residents or citizens of or who have an address in, or who otherwise appear to the Company or SLC Registrars to be connected to, the United States (or any of its territories or possessions), Canada, Australia, Japan, Belarus or Russia.
For further information please contact:
|
Open Orphan plc |
+353 (0) 1 644 0007 |
||
|
Cathal Friel, Executive Chairman Yamin Khan, Chief Executive Officer |
|||
|
Arden Partners plc (Nominated Adviser and Joint Broker) |
+44 (0) 20 7614 5900 |
||
|
John Llewellyn-Lloyd / Louisa Waddell |
|||
|
finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
||
|
Geoff Nash / James Thompson / Richard Chambers |
|||
|
Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
||
|
Anthony Farrell |
|||
|
Walbrook PR (Financial PR & IR) Paul McManus / Sam Allen / Louis Ashe-Jepson |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com +44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393 |
||
Notes to Editors
Open Orphan plc
Open Orphan plc (London and Euronext: ORPH) is a rapidly growing contract research company that is a world leader in testing infectious and respiratory disease products using human challenge clinical trials. The Company provides services to Big Pharma, biotech, and government/public health organisations.
The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases, including the recently established COVID-19 model, and is developing a number of new models, such as Malaria, to address the dramatic growth of the global infectious disease market. The Paris and Breda offices have over 25 years of experience providing drug development services such as biometry, data management, statistics CMC, PK and medical writing to third party clients as well as supporting the London-based challenge studies.
Open Orphan runs challenge studies in London from its Whitechapel quarantine clinic, its state-of-the-art QMB clinic with its highly specialised on-site virology and immunology laboratory, and its newly opened clinic in Plumbers Row. To recruit volunteers / patients for its studies, the Company leverages its unique clinical trial recruitment capacity via its FluCamp volunteer screening facilities in London and Manchester. The newly opened facilities have expanded the scope of the business to enable the offering of Phase I and Phase II vaccine field trials, PK studies, bridging studies, and patient trials as part of large international multi-centre studies.
Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological, and digital (wearable) biomarkers.
About Poolbeg Pharma
Poolbeg Pharma is a clinical stage infectious disease pharmaceutical company, with a capital light clinical model which aims to develop multiple products faster and more cost effectively than the conventional biotech model. The Company, headquartered in London, is led by a team with a track record of creation and delivery of shareholder value and aspires to become a “one-stop shop” for Big Pharma seeking mid-stage products to license or acquire.
The Company is targeting the growing infectious disease market. In the wake of the COVID-19 pandemic, infectious disease has become one of the fastest growing pharma markets and is expected to exceed $250bn by 2025.
With its initial assets from Open Orphan plc , an industry leading infectious disease and human challenge trials business, Poolbeg has access to knowledge, experience, and clinical data from over 20 years of human challenge trials. The Company is using these insights to acquire new assets as well as reposition clinical stage products, reducing spend and risk. Amongst its portfolio of exciting assets, Poolbeg has a small molecule immunomodulator for severe influenza (POLB 001); a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections (POLB 002); and a vaccine for Melioidosis (POLB 003). The Company is also developing an oral vaccine delivery platform and is progressing two artificial intelligence (AI) drug discovery programmes to accelerate the power of its human challenge model data and biobank.
For more information, please go to www.poolbegpharma.com or follow us @PoolbegPharma
Open Orphan #ORPH – Presentation at World Vaccine Congress
Presentation at World Vaccine Congress
hVIVO presents on the outcomes from the world’s first COVID-19 characterisation study
Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, a subsidiary of Open Orphan plc, will be delivering a presentation at the World Vaccine Congress, Washington D.C., United States, titled ‘Outcome of the world’s first SARS-CoV-2 viral challenge and its utility for vaccine testing’.
Dr Catchpole will be presenting the results from the world’s first COVID-19 characterisation study, which was a partnership between hVIVO, Imperial College London, the Vaccine Taskforce and Department of Health and Social Care (DHSC), and the Royal Free London NHS Foundation Trust. The landmark study, published in Nature Medicine on 31 March 2022, found that a SARS-CoV-2 human challenge is safe in healthy young adults and provided detailed insights into the course of COVID-19 infection with potential positive public health implications, which will also be outlined in Dr Catchpole’s presentation.
Full details of the presentation are included below:
|
Title |
Outcome of the world’s first SARS-CoV-2 viral challenge and its utility for vaccine testing |
|
Date/Time |
Wednesday 20 April 2022, 09.40 am (ET) |
The World Vaccine Congress will take place at the Marriott Marquis in Washington DC between 18-21 April 2022. hVIVO will be at booth 410 during the congress for potential partnering discussions.
The World Vaccine Congress is the largest and most established meeting dedicated to vaccines and has run for 21 years. In that period, it has evolved and grown into the leading vaccines congress globally, with hundreds of speakers and thousands of attendees from leading global vaccines developers, academia and policymakers.
More information about the event, including attendance, can be found here .
Yamin ‘Mo’ Khan, Chief Executive Officer at Open Orphan, said: “I am delighted that Andrew will be presenting at the largest vaccine event of the year, highlighting the pivotal role hVIVO played in the world’s first COVID-19 characterisation study.”
Interested in becoming a volunteer?
hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com . By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.
For further information please contact:
|
Open Orphan plc |
+353 (0) 1 644 0007 |
||
|
Cathal Friel, Executive Chairman |
|||
|
Arden Partners plc (Nominated Adviser and Joint Broker) |
+44 (0) 20 7614 5900 |
||
|
John Llewellyn-Lloyd / Louisa Waddell |
|||
|
finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
||
|
Geoff Nash / James Thompson / Richard Chambers |
|||
|
Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
||
|
Anthony Farrell |
|||
|
Walbrook PR (Financial PR & IR) Paul McManus / Sam Allen / Louis Ashe-Jepson |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com +44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0)7747 515 393 |
||
Open Orphan #ORPH – COVID-19 Characterisation Study peer reviewed results published in industry leading periodical Nature Medicine
Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that the results from the world’s first COVID-19 characterisation study have been peer reviewed and published in the scientific journal Nature Medicine.
‘Safety, tolerability and viral kinetics during SARS-CoV-2 human challenge’ by Killingley, B. et al. is available in Nature Medicine, https://www.nature.com/articles/s41591-022-01780-9 DOI: 10.1038/s41591-022-01780-9
The study, which was conducted by hVIVO, a subsidiary of Open Orphan, in partnership with Imperial College London, the Vaccine Taskforce and Department of Health and Social Care (DHSC), and the Royal Free London NHS Foundation Trust, showed that the SARS-CoV-2 human challenge was safe in healthy young adults and provided detailed insights into the course of COVID-19 infection with potential positive public health implications. The study results had previously been published on Research Square whilst the peer review process was concluding.
As part of the characterisation study, researchers aimed to identify a dose of COVID-19 that caused a safe and reliable infection in unvaccinated volunteers with no prior SARS-CoV-2 infection. hVIVO clinicians closely monitored volunteers in a controlled quarantined setting and collected disease progression data to provide insights into COVID-19 infection.
With the characterisation study disease modelling data completed, and a COVID-19 Human Challenge Model now established, Open Orphan should be able to contract / conduct COVID-19 human challenge studies in 2022, subject to individual ethics and regulatory approvals.
Dr Andrew Catchpole, Co-investigator on the study and Chief Scientific Officer of hVIVO, said : “The SARS-CoV-2 characterisation study has provided invaluable insights into the progression of COVID-19 infection in healthy young adults. We are delighted to see the peer reviewed results published in Nature Medicine, which is one of the most influential and highly-cited medical research journals, and is an indication of how important the study was in helping deepen our understanding of SARS-CoV-2.”
Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “I am pleased to see the characterisation study paper successfully complete the peer review process and be published in such a prestigious journal. Looking forward to the rest of the year, the COVID-19 human challenge model has the potential to accelerate the development of novel therapeutics and vaccines. We look forward to updating the market in due course.”
Interested in becoming a volunteer?
hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com . By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.
For further information please contact:
|
Open Orphan plc |
+353 (0) 1 644 0007 |
||
|
Cathal Friel, Executive Chairman Yamin Khan, Chief Executive Officer |
|
||
|
|
|
||
|
Arden Partners plc (Nominated Adviser and Joint Broker) |
+44 (0) 20 7614 5900 |
||
|
John Llewellyn-Lloyd / Louisa Waddell |
|
||
|
|
|
||
|
finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
||
|
Geoff Nash / James Thompson / Richard Chambers |
|
||
|
|
|
||
|
Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
||
|
Anthony Farrell |
|
||
|
|
|
||
|
Walbrook PR (Financial PR & IR) Paul McManus / Sam Allen / Louis Ashe-Jepson |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com +44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393 |
||
Notes to Editors
Open Orphan plc
Open Orphan plc (London and Euronext: ORPH) is a rapidly growing contract research company that is a world leader in testing infectious and respiratory disease products using human challenge clinical trials. The Company provides services to Big Pharma, biotech, and government/public health organisations.
The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models, such as malaria and COVID-19, to address the dramatic growth of the global infectious disease market. The Paris and Breda offices have over 25 years of experience providing drug development services such as biometry, data management, statistics CMC, PK and medical writing to third party clients as well as supporting the London-based challenge studies.
Open Orphan runs challenge studies in London from its Whitechapel quarantine clinic, its state-of-the-art QMB clinic with its highly specialised on-site virology and immunology laboratory, and its newly opened clinic in Plumbers Row. To recruit volunteers / patients for its studies, the Company leverages its unique clinical trial recruitment capacity via its FluCamp volunteer screening facilities in London and Manchester. The newly opened facilities have expanded the scope of the business to enable the offering of Phase I and Phase II vaccine field trials, PK studies, bridging studies, and patient trials as part of large international multi-centre studies.
Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological, and digital (wearable) biomarkers.
Open Orphan #ORPH – Trading Update, Volunteer Recruitment and Laboratory Facilities Expansion
Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, provides a trading update for the year ended 31 December 2021. The Company also announces it will be opening a new primary FluCamp volunteer recruitment screening facility in Plumbers Row, London (“Plumbers Row Facility”) and a secondary FluCamp recruitment facility in Manchester.
Trading Update
Subject to completion of the audit, the Company expects both revenues and EBITDA to be in line with the expectation detailed at the time of the interim results. Accordingly the Company expects 2021 to be EBITDA positive with revenues of approximately £40m. Cash and cash equivalents as of 31 December 2021 was £15.6m (30 June 2021: £14.9m). The Company further expects to be in line with management expectations for year-ending 31 December 2022, targeting revenues in the region of £50m in non-COVID-19 work. COVID-19 revenue for 2022 will be in addition to this and will depend on the eventual timing of these studies.
Facilities Expansion
The new facilities will double the Company’s previous volunteer screening capacity, significantly boosting its ability to identify and enrol study volunteers and patients and further strengthening its world leading human challenge capabilities.
As part of the opening of a new specialised volunteer recruitment facility in London, the Whitechapel quarantine clinic and the Queen Mary’s Bioenterprises Centre (“QMB”) clinic will both be exclusively dedicated to conducting human challenge studies going forward. The space at QMB currently providing volunteer screening will be converted into further quarantine bedrooms. As such, the Company’s QMB facility will expand to 31 beds, adding to the Whitechapel Clinic’s 19 beds and the Plumbers Row Facility’s 12; in total the Company’s bed count will reach 62. These new facilities offer an opportunity to the Company to expand the scope of the business to offer Phase I and Phase II vaccine field trials, PK (pharmacokinetics) studies, bridging studies, and patient trials (as opposed to healthy volunteer human challenge trials) as part of large international multi-centre studies which do not require a quarantine setting.
The increase in volunteer recruitment capacity will enable the Company to recruit larger cohorts more quickly than before and cement Open Orphan’s world leading position and reputation in volunteer recruitment. Particularly in Manchester, the secondary facility extends the Company’s reach for more volunteers and facilitates the increasing demand for human challenge studies. During volunteer screening there are large numbers of volunteers that are ineligible to take part in challenge studies for a variety of reasons, such as previous infection by the virus under investigation. By broadening the business offering to include Phase I and Phase II field trials, a large proportion of the volunteers already in the FluCamp facility could be eligible to take part in these studies.
The Plumbers Row Facility, London, plus the volunteer recruitment facility in Manchester, will have additional laboratory capacity, meaning samples collected during volunteer screening visits can be processed and stabilised on site. As a result, the primary laboratory at QMB has the capacity to expand its virology lab services business and increases its biomarker and molecular testing capabilities.
In addition, the Company’s corporate office will move from Alie Street to an upper floor in Plumbers Row. Both London and Manchester facilities offered attractive terms; the new Plumbers Row space is c. 9,000 sq ft and is a third of the cost of the current space of 4,000 sq ft; the new Manchester facility comes at the same cost as the old facility, but with four times the floor space at c. 2,000 sq ft.
Cathal Friel, Executive Chairman of Open Orphan, said: “Despite difficult market conditions during the year, which have continued into 2022, I am pleased with the performance of the Open Orphan team and during 2021 we signed an impressive number of human challenge study contracts with Big Pharma and biotechnology clients.
“We have continued our strong work at the start of this year, and our new facilities in both London and Manchester will not only enable the Company to screen a greater number of potential volunteers, it will also increase our total bed count to 62. Considering the greater size and functionality of the new facilities, as well as their cost, the Company has executed the expansion in a highly cost-efficient manner.”
Yamin Khan, Chief Executive Officer of Open Orphan, said: “I am delighted to be opening a new primary FluCamp volunteer recruitment and screening facility within walking distance from our other Whitechapel facilities as well as a new, larger Manchester volunteer recruitment facility. These facilities double our volunteer screening capacity and importantly, expand on our already world leading clinical trial and laboratory services offering.
“As a result of the changes, we have the potential to expand the scope of our business as we head into a crucial period of substantial growth across the infectious disease market. I believe we are now very well positioned with an enhanced clinical trial offering and unique volunteer and patient recruitment capacity, which will enable us to serve an increasing pool of Big Pharma and biotechnology clients seeking to test novel therapeutics against different infectious and respiratory diseases.”
Robin Rogiers, Director of Clinical Delivery & Innovation of hVIVO, said: “The opening of the new primary and secondary FluCamp volunteer facilities means we now boast a truly world class clinical trial offering. With quarantine capacity significantly increased and volunteer recruitment capacity doubled, we will be able to expand the scope of our clinical trial business to include vaccine field trials, PK studies, bridging studies and patient trials as part of large international multi-centre studies. The increased scope also includes an enhanced virology lab services offering at QMB, which will now be able to increase its biomarker and molecular testing capabilities.”
Interested in becoming a volunteer?
hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.
For further information please contact:
|
Open Orphan plc |
+353 (0) 1 644 0007 |
||
|
Cathal Friel, Executive Chairman Yamin Khan, Chief Executive Officer |
|
||
|
|
|
||
|
Arden Partners plc (Nominated Adviser and Joint Broker) |
+44 (0) 20 7614 5900 |
||
|
John Llewellyn-Lloyd / Louisa Waddell |
|
||
|
|
|
||
|
finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
||
|
Geoff Nash / James Thompson / Richard Chambers |
|
||
|
|
|
||
|
Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
||
|
Anthony Farrell |
|
||
|
|
|
||
|
Walbrook PR (Financial PR & IR) Paul McManus / Sam Allen / Louis Ashe-Jepson |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com +44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393 |
||
Notes to Editors
Open Orphan plc
Open Orphan plc (London and Euronext: ORPH) is a rapidly growing contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The Company provides services to Big Pharma, biotech, and government/public health organisations.
Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic and its state-of-the-art 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models. There has been significant growth of the infectious disease market, which is estimated to grow to in excess of $250bn by 2025. The Group is focused on refreshing its existing challenge models and develop new models, such as Malaria, to address the dramatic growth potential of the global infectious disease market.
Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological, and digital (wearable) biomarkers. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma, and biotech companies.
Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing, and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts
Open Orphan #ORPH – Investor presentations to provide introduction to new CEO Yamin ‘Mo’ Khan
Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces it will provide two live investor presentations in March 2022. The presentations will provide investors with an introduction to new Chief Executive Officer, Yamin ‘Mo’ Khan, who will make his maiden presentations on Company progress.
London South East
Executive Chairman, Cathal Friel, and Chief Executive Officer, Yamin ‘Mo’ Khan, will give a live investor presentation via London South East alongside other companies as part of an investor webinar on Tuesday 8 March at 7.30 pm (GMT). The presentation is free to attend and requires investors to register via the London South East website. This can be accessed with the following link:
https://us02web.zoom.us/webinar/register/3816460478728/WN_kyeX1ibCT0aXEUdkO9gIOg
Investor Meet Company
Executive Chairman, Cathal Friel, and Chief Executive Officer, Yamin ‘Mo’ Khan, will host a second investor presentation via Investor Meet Company (“IMC”) on Tuesday 15 March at 6.00 pm (GMT). Investors can sign up to Investor Meet Company for free and request to meet Open Orphan plc via the following link:
https://www.investormeetcompany.com/open-orphan-plc/register-investor
Investors who already follow Open Orphan plc on the Investor Meet Company platform will automatically be invited.
Questions can be submitted pre-event via your IMC dashboard or in real time during the presentation. Whilst the Company may not be in a position to answer every question it receives, it will address the most prominent within the confines of regulations and information already disclosed to the market through regulatory notifications. A recording of the presentation will be available on the Investor Meet Company platform afterwards. No new price sensitive information will be disclosed, and a PDF of the presentation will be uploaded to the Company’s website.
For further information please contact:
| Open Orphan plc | +353 (0) 1 644 0007 | ||
| Cathal Friel, Executive Chairman | |||
| Yamin Khan, Chief Executive Officer | |||
| Arden Partners plc (Nominated Adviser and Joint Broker) | +44 (0) 20 7614 5900 | ||
| John Llewellyn-Lloyd / Louisa Waddell | |||
| finnCap plc (Joint Broker) | +44 (0) 20 7220 0500 | ||
| Geoff Nash / James Thompson / Richard Chambers | |||
| Davy (Euronext Growth Adviser and Joint Broker) | +353 (0) 1 679 6363 | ||
| Anthony Farrell | |||
| Walbrook PR (Financial PR & IR)
Paul McManus / Sam Allen / Louis Ashe-Jepson |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com
+44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393 |
||
Notes to Editors
Open Orphan plc
Open Orphan plc (London and Euronext: ORPH) is a rapidly growing contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The Company provides services to Big Pharma, biotech, and government/public health organisations.
Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic and its state-of-the-art 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models. There has been significant growth of the infectious disease market, which is estimated to grow to in excess of $250bn by 2025. The Group is focused on refreshing its existing challenge models and develop new models, such as Malaria, to address the dramatic growth potential of the global infectious disease market.
Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological, and digital (wearable) biomarkers. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma, and biotech companies.
Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing, and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.
Open Orphan #ORPH – FDA Breakthrough Designation for Big Pharma RSV candidate
Vaccine candidate assessed in successful human challenge trial conducted by hVIVO
Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, notes the announcement dated 14 February 2022 from Bavarian Nordic A/S (“Bavarian Nordic”) (OMX: BAVA), reporting that the US Food and Drug Administration (“FDA”) has granted Breakthrough Therapy Designation for Bavarian Nordic’s respiratorysyncytial virus (“RSV”) vaccine candidate, MVA-BN® RSV. hVIVO, a subsidiary of Open Orphan, successfully conducted a Phase 2, double-blinded, placebo controlled human challenge trial to assess MVA-BN® RSV using its RSV Human Challenge Study Model.
A Breakthrough Therapy Designation is designed to expedite the development and regulatory review of medicines that are intended to treat a serious condition. The designation has been granted upon the assessment of preliminary clinical evidence for MVA-BN RSV, indicating that the vaccine candidate may demonstrate substantial improvement over available therapy on a clinically significant endpoint. A significant portion of this preliminary evidence was the successful challenge study conducted by hVIVO. The designation provides an option to work more closely with FDA for the development and review of MVA-BN RSV.
The challenge study conducted by hVIVO to assess MVA-BN® RSV demonstrated a significant reduction in viral load in vaccinated subjects versus placebo, thus meeting the primary endpoint of the study. At the same time, vaccinated subjects showed a significant reduction in clinical symptoms typically associated with RSV infections. The MVA-BN RSV vaccine demonstrated a vaccine efficacy of up to 79% in preventing symptomatic RSV infections. No vaccine-related serious adverse events were observed, and the vaccine was well tolerated, consistent with the safety profile previously reported in Phase 1 and Phase 2 clinical studies.
RSV is a contagious, common respiratory virus that usually causes mild, cold-like symptoms and affects the respiratory tract of children and at-risk older adults; in severe cases, it can cause pneumonia and other life-threatening breathing difficulties. RSV is a significant public health threat and is one of the leading causes of hospitalisation to at-risk older adults.
hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of infectious and respiratory disease areas, including various strains of influenza, RSV, HRV, COVID-19, asthma and malaria, etc.
Cathal Friel, Executive Chairman, said: “We are pleased to see Bavarian Nordic achieve Breakthrough Therapy Designation for its RSV vaccine candidate, MVA-BN® RSV. hVIVO successfully conducted a human challenge trial on behalf of Bavarian Nordic in 2021, where the candidate showed a significant reduction in clinical symptoms associated with RSV.
“The data from this human challenge trial was part of the body of evidence provided by Bavarian Nordic to the FDA in order to secure its Breakthrough Therapy Designation, which could ultimately result in an expedited regulatory review of MVA-BN® RSV. This highlights a major benefit of human challenge trials, in that they enable drug developers to obtain Phase 2/2a efficacy data for their vaccine and antivirals candidates in a fast, cost-effective manner ahead of larger scale studies. This data can then strengthen submissions for important regulatory programmes such as the Breakthrough Therapy Designation.”
Interested in becoming a volunteer?
hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.
Individuals interested in taking part in COVID-19 human challenge study research can learn more at www.UKCovidChallenge.com.
For further information please contact:
| Open Orphan plc | +353 (0) 1 644 0007 | |||
| Cathal Friel, Executive Chairman | ||||
| Arden Partners plc (Nominated Adviser and Joint Broker) | +44 (0) 20 7614 5900 | |||
| John Llewellyn-Lloyd / Louisa Waddell | ||||
| finnCap plc (Joint Broker) | +44 (0) 20 7220 0500 | |||
| Geoff Nash / James Thompson / Richard Chambers | ||||
| Davy (Euronext Growth Adviser and Joint Broker) | +353 (0) 1 679 6363 | |||
| Anthony Farrell | ||||
| Walbrook PR (Financial PR & IR) | +44 (0)20 7933 8780 or openorphan@walbrookpr.com | |||
| Paul McManus/ Sam Allen / Louis Ashe-Jepson | +44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393 | |||
Notes to Editors
Open Orphan plc
Open Orphan plc (London and Euronext: ORPH) is a rapidly growing contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The Company provides services to Big Pharma, biotech and government/public health organisations.
Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic and its state-of-the-art 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models. There has been an explosion in the growth of the infectious disease market, which is estimated to grow to in excess of $250bn by 2025. The Group is focused on refreshing its existing challenge models and develop new models, such as Malaria, to address the dramatic growth potential of the global infectious disease market.
Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological and digital (wearable) biomarkers. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies.
Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.